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NDC 00168-0323-46 Metronidazole 7.5 mg/g Details
Metronidazole 7.5 mg/g
Metronidazole is a TOPICAL CREAM in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Fougera Pharmaceuticals Inc.. The primary component is METRONIDAZOLE.
MedlinePlus Drug Summary
Metronidazole is used to treat rosacea (a skin disease that causes redness, flushing, and pimples on the face). Metronidazole is in a class of medications called nitroimidazole antimicrobials. It works by stopping the growth of bacteria.
Related Packages: 00168-0323-46Last Updated: 11/30/2022
MedLinePlus Full Drug Details: Metronidazole Topical
Product Information
| NDC | 00168-0323 |
|---|---|
| Product ID | 0168-0323_bfe32c3b-9d0e-4438-8417-3f948262b37d |
| Associated GPIs | 90060040003710 |
| GCN Sequence Number | 041799 |
| GCN Sequence Number Description | metronidazole CREAM (G) 0.75 % TOPICAL |
| HIC3 | L5G |
| HIC3 Description | ROSACEA AGENTS, TOPICAL |
| GCN | 43203 |
| HICL Sequence Number | 004157 |
| HICL Sequence Number Description | METRONIDAZOLE |
| Brand/Generic | Generic |
| Proprietary Name | Metronidazole |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | Metronidazole |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | CREAM |
| Route | TOPICAL |
| Active Ingredient Strength | 7.5 |
| Active Ingredient Units | mg/g |
| Substance Name | METRONIDAZOLE |
| Labeler Name | Fougera Pharmaceuticals Inc. |
| Pharmaceutical Class | Nitroimidazole Antimicrobial [EPC], Nitroimidazoles [CS] |
| DEA Schedule | n/a |
| Marketing Category | ANDA |
| Application Number | ANDA076408 |
| Listing Certified Through | 2024-12-31 |
Package
Package Images
NDC 00168-0323-46 (00168032346)
| NDC Package Code | 0168-0323-46 |
|---|---|
| Billing NDC | 00168032346 |
| Package | 45 g in 1 TUBE (0168-0323-46) |
| Marketing Start Date | 2004-05-28 |
| NDC Exclude Flag | N |
| Pricing Information | |
| Price Per Unit | 0.35622 |
| Pricing Unit | GM |
| Effective Date | 2024-02-21 |
| NDC Description | METRONIDAZOLE 0.75% CREAM |
| Pharmacy Type Indicator | C/I |
| OTC | N |
| Explanation Code | 1, 5 |
| Classification for Rate Setting | G |
| As of Date | 2024-02-21 |
Standard Product Labeling (SPL)/Prescribing Information SPL 43ed872b-63ac-4a22-9c9e-cc0e05bcc41e Details
DESCRIPTION
Metronidazole Topical Cream contains metronidazole, USP, at a concentration of 7.5 mg per gram (0.75%) in an emollient cream consisting of emulsifying wax, sorbitol solution, glycerin, isopropyl palmitate, benzyl alcohol, lactic acid, and/or sodium hydroxide to adjust pH, and purified water. Metronidazole is a member of the imidazole class of anti-bacterial agents and is classified therapeutically as an antiprotozoal and antibacterial agent. Chemically, metronidazole is 2-Methyl-5-nitroimidazole-1-ethanol. The molecular formula is C6H9N3O3 and molecular weight is 171.16. Metronidazole is represented by the following structural formula:
CLINICAL PHARMACOLOGY
INDICATIONS AND USAGE
CONTRAINDICATIONS
PRECAUTIONS
General: Topical metronidazole has been reported to cause tearing of the eyes. Therefore, contact with the eyes should be avoided. If a reaction suggesting local irritation occurs, patients should be directed to use the medication less frequently or discontinue use. Metronidazole is a nitroimidazole and should be used with care in patients with evidence of, or history of blood dyscrasia.
Information for patients: This medication is to be used as directed by the physician. It is for external use only. Avoid contact with the eyes.
Drug interactions: Oral metronidazole has been reported to potentiate the anticoagulant effect of warfarin and coumarin anticoagulants, resulting in a prolongation of prothrombin time. The effect of topical metronidazole on prothrombin time is not known.
Carcinogenesis, mutagenesis, impairment of fertility: Metronidazole has shown evidence of carcinogenic activity in a number of studies involving chronic, oral administration in mice and rats but not in studies involving hamsters.
Metronidazole has shown evidence of mutagenic activity in several in vitro bacterial assay systems. In addition, a dose-response increase in the frequency of micronuclei was observed in mice after intraperitoneal injections and an increase in chromosome aberrations have been reported in patients with Crohn's disease who were treated with 200-1200 mg/day of metronidazole for 1 to 24 months. However, no excess chromosomal aberrations in circulating human lymphocytes have been observed in patients treated for 8 months.
Pregnancy: Teratogenic effects: Pregnancy category B
There are no adequate and well-controlled studies with the use of metronidazole topical cream in pregnant women. Metronidazole crosses the placental barrier and enters the fetal circulation rapidly. No fetotoxicity was observed after oral metronidazole in rats or mice. However, because animal reproduction studies are not always predictive of human response and since oral metronidazole has been shown to be a carcinogen in some rodents, this drug should be used during pregnancy only if clearly needed.
Nursing mothers: After oral administration, metronidazole is secreted in breast milk in concentrations similar to those found in the plasma. Even though blood levels are significantly lower with topically applied metronidazole than those achieved after oral administration of metronidazole, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.
ADVERSE REACTIONS
In controlled clinical trials, the total incidence of adverse reactions associated with the use of metronidazole topical cream was approximately 10%. Skin discomfort (burning and stinging) was the most frequently reported event followed by erythema, skin irritation, pruritus and worsening of rosacea. All individual events occurred in less than 3% of patients.
The following additional adverse experiences have been reported with the topical use of metronidazole: dryness, transient redness, metallic taste, tingling or numbness of extremities and nausea.
DOSAGE AND ADMINISTRATION
PRINCIPAL DISPLAY PANEL
PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 45 GRAM TUBE
NDC 0168-0323-46
Fougera®
METRONIDAZOLE
TOPICAL CREAM
0.75%
Rx only
FOR TOPICAL USE ONLY
NOT FOR OPHTHALMIC USE
Store at 20°C to 25°C (68°F to 77°F), excursions permitted 15°C to 30°C
(59°F to 86°F). [See USP Controlled Room Temperature].
KEEP OUT OF THE REACH OF CHILDREN.
NET WT 45 grams
PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
| METRONIDAZOLE
metronidazole cream |
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| Labeler - Fougera Pharmaceuticals Inc. (043838424) |